Comparsion of continuous paravertebral blockade and continuous wound catheter infiltration for analgesia following mastectomy.

INTERVENTION: Trade Name: Chirocaine Product Name: Levobupivicaine Product Code: N01BB10 Pharmaceutical Form: Solution for infusion CAS Number: 27262‐48‐2 Other descriptive name: LEVOBUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 1.25‐2.5 CONDITION: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] This study will involve the administration of levobupivicaine 0.125% and 0.25%, a local anaesthetic agent licensed for this purpose into the paravertebral space and into the surgical wound, to provide postoperative analgesia for adults having a mastecomy. We aim to compare the analgesia efficacy of paravertebral blockade with surgical wound blockade for post operative pain in the first 48 hours. ; MedDRA version: 14.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 ‐ Injury, poisoning and procedural complications PRIMARY OUTCOME: Main Objective: We aim to compare the analgesic efficacy of continuous paravertebral blockade and continuous wound infiltration with a control, for post operative pain in the first 48 post operative hours, following mastectomy and, in a randomised controlled single blinded clinical trial. ; ; Primary Measures: ; Total opiate usage in the first 48 hours after surgery; ; Primary end point(s): Total opiate usage in the first 48 hours after surgery Secondary Objective: Poorly controlled analgesia is associated with prolongation of hospital stay and increased morbidity. The use of paravertebral nerve blocks, wound catheters and morphine PCA's (patient controlled analgesia) are well established approaches to post operative analgesia. We plan to show that both paravertebral and wound catheters will provide very satisfactory analgesia post operatively.; Morphine is associated with sedation, nausea, vomiting and itch. We plan to show a statistically significant decrease in these side effects in the paravertebral and wound infiltration groups.; We will also look at patient satisfaction Timepoint(s) of evaluation of this end point: 48 hours SECONDARY OUTCOME: Secondary end point(s): Severity of Postoperative Pain, [VAS and Categorical pain Scales]; Sedation ; Postoperative nausea, vomiting and itch; Patient Satisfaction; Timepoint(s) of evaluation of this end point: 48 hours INCLUSION CRITERIA: Adults (aged 18‐80) presenting for elective mastectomy + axillary surgery ASA 1 to 3 Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45